Naming Rules for Medical Devices in China: A Practical Guide

Introduction

The naming of medical devices is a critical aspect of regulatory approval and market transparency in China. Based on the General Principles for Naming Medical Devices (2019), this guide provides a comprehensive overview for manufacturers, regulators, and stakeholders involved in the development and marketing of medical devices in China.

 


Scope

The guidelines apply to all medical devices except for in vitro diagnostic reagents regulated as medical devices. The document provides naming principles for both general categories and specific domain-level naming guidance.

 


Structure of General Names

Each general name consists of:

  • Core term (核心词): Describes the technical principle, structural composition, or intended use.
  • Up to three characteristic terms (特征词): Describe specific features such as usage site, form, technology, or materials.

 


Guiding Principles for Name Composition

  • Names should be clear, standardized, and non-promotional.
  • Priority is given to technical accuracy and clinical relevance.
  • Characteristic terms should be ordered from general to specific, starting with usage or delivery form.

 


Terminology Tables

Each domain develops a terminology table including:

  • Serial number
  • Product category
  • Term type (core/characteristic)
  • Term name
  • Term description

 


Example: Naming of Implantable Neurostimulators

To clarify the naming structure, here’s a full example of how to construct a general name for a category of devices:

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Serial No. Product Category Term Type Term Name Term Description
1 Implantable Neurostimulator Core Term Neurostimulator Applies electrical pulses to specific areas of the brain or nervous system to treat Parkinson’s disease, control epilepsy, chronic intractable pain, bowel/bladder control, dystonia, and other neuromodulation-related conditions.
Characteristic Term 1 – Usage Form Implantable Implanted into the human body.
Characteristic Term 2 – Technical Feature Non-rechargeable (Default) The battery is not rechargeable.
Characteristic Term 2 – Technical Feature Rechargeable The battery can be wirelessly recharged externally.
Characteristic Term 3 – Application Site Deep Brain / Spinal Cord / Sacral / Vagus Stimulation output targets deep brain, spinal cord, sacral nerve, or vagus nerve.

Name Composition Examples

  • 植入式脑深部神经刺激器
    (Implantable Deep Brain Neurostimulator – non-rechargeable implied)
  • 植入式可充电脊髓神经刺激器
    (Implantable Rechargeable Spinal Neurostimulator)

This structured naming ensures clarity for both regulatory review and clinical use, avoiding brand ambiguity or over-commercialization.

 


Brand Naming and Market Considerations in China

1 The Role of Product Brand Names

While general names are standardized and non-commercial, product brand names (商品名/品牌名) and model identifiers play an important marketing role and are often included in labeling and promotional materials.


2 Best Practices for Brand Naming in China

To ensure brand success and regulatory clarity:

  • Avoid overlap with general names or misleading terms.
  • Use pinyin, short Chinese characters, or alphanumeric combinations that resonate with local audiences.
  • Consider controlled vocabulary sets that signal function or prestige while maintaining uniqueness.



3 Examples of Effective Brand Names

Brand names often used in model numbers or variants include:

  • “安舒神” (AnShuShen) – used in neuromodulation devices, implying comfort and nerve calm.
  • “微智控” (WeiZhiKong) – for smart micro-controlled devices.
  • “润和” (RunHe) – evoking harmony and smooth function in implants.
  • “心安通” (XinAnTong) – widely used in cardiovascular devices, implying heart safety and connection.

These names are typically followed by model identifiers (e.g., “微智控 iStim-R3”) to create a commercial identity distinct from the regulated general name.

 

Conclusion

China’s medical device naming system emphasizes clarity, standardization, and clinical accuracy. While general names serve a regulatory purpose, brand names provide room for market positioning. A well-balanced strategy combining regulatory naming discipline with strategic brand generation is key to long-term success